(58 days)
The Triage Total Controls 5 are assayed materials to be used with the Triage® Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to assist in monitoring test performance.
The Triage Total Calibration Verification 5 materials are to be used with the Triage Profiler S.O.B.™ Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to verify the calibration of the Test Devices throughout the measurable range.
The Triage Total Controls 5 Control 1 and 2, and Triage Total Calibration Verification 5 Levels A, B, C, D, E are single-use, 0.29 mL unit dose quality control materials prepared with concentrated purified CK-MB, myoglobin, troponin I, BNP and D-Dimer and human EDTA plasma at defined levels. The controls are stored frozen at
The provided text is a 510(k) summary for Triage Total Controls 5 / Triage Total Calibration Verification 5. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain information related to specific acceptance criteria or the details of a study that proves the device meets those criteria.
Instead of presenting quantitative acceptance criteria and detailed study results, the document states:
- "The stability of the Triage Total Controls 5 and the Triage Total Calibration Verification 5 have been validated according to established procedures at the manufacturing site."
- "The performance of the control materials are similar to other products in commercial distribution intended for similar use."
- "The Triage Total Controls 5 and Triage Total Calibration Verification 5 employ similar characteristics to the predicate device including multi-analytes assay control, 5 levels, liquid control, EDTA human plasma matrix and ≤ -20℃ storage condition."
- "The information presented in this Premarket Notification demonstrates the suitability of the device for laboratory and professional use. Such studies are a critical element in establishing the fundamental safety and effectiveness of the product and its appropriateness for commercial distribution."
Therefore, based solely on the provided text, I cannot fill out the requested table and answer many of the detailed questions about the study design, sample size, ground truth, and expert involvement.
Here's what can be stated based on the provided text, and where gaps exist:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "stability...validated according to established procedures" |
| Not specified in the document | "performance...similar to other products in commercial distribution intended for similar use" |
| Not specified in the document | "substantially equivalent in intended use and performance to the Triage Profiler S.O.B. Controls and the Triage Profiler S.O.B. Calibration Verification Controls" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "established procedures at the manufacturing site," implying internal company testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This device is a quality control material for in vitro diagnostic tests, not an AI/imaging device requiring expert interpretation of results for ground truth. Therefore, this question is not applicable in the context of this 510(k) summary. The ground truth for this type of device would typically be established through analytical methods and certified reference materials or established laboratory methods.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an AI/imaging device requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a quality control material and not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- While not explicitly stated as "ground truth," the performance of quality control materials is typically verified against:
- Defined levels: The document states they are "prepared with concentrated purified CK-MB, myoglobin, troponin I, BNP and D-Dimer and human EDTA plasma at defined levels." These defined levels act as the analytical "ground truth."
- Established analytical methods: Performance would be compared to expected values using reference methods or the target Triage® test systems.
8. The sample size for the training set
- Not applicable. This is a quality control material, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. This device does not have a "training set" in the context of machine learning.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.